Cleared Traditional

RUBELLACOL

K031490 · Immunostics Inc., · Microbiology
Jul 2003
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K031490 is an FDA 510(k) clearance for the RUBELLACOL, a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on July 16, 2003, 65 days after receiving the submission on May 12, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K031490 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2003
Decision Date July 16, 2003
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LQN — Latex Agglutination Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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